Evaluate the Chemistry, Manufacturing and Controls (CMC) data of therapeutic product applications for regulatory approval to assure the quality of medicines supplied in Singapore
Provide advice / guidance on the regulatory requirements and procedures for therapeutic product regulatory submissions, and to respond to enquiries from industry and healthcare stakeholders as well as member of public
Participate in projects and process/regulatory review
Job Requirements
Possess knowledge and experience in related scientific disciplines, e.g., molecular biology, biochemistry, chemistry. pharmacy or related disciplines
Experienced in pharmaceutical manufacturing and quality control of biologics and/or chemcial drug products
Experience in the area of analytical assay development would be an advantage.
Knowledge of chemistry/molecular biology and manufacturing of pharmaceuticals / biologics
Knowledge of drug development process and drug regulations
Knowledge of international regulatory guidelines
Good communication and interpersonal skills
Able to work independently, as well as in a team
Able to work effectively with people from different backgrounds
Highly motivated with strong desire to protect public health and safety